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Trials / Completed

CompletedNCT07241455

Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Istanbul Medeniyet University · Academic / Other
Sex
All
Age
2 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). We will assess content validity with an expert panel, feasibility in a pilot run, test-retest reliability, internal consistency, and criterion validity against established clinical scores.

Detailed description

This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the Turkish version of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) for use in pediatric intensive care settings. The study will be conducted in the Pediatric Intensive Care Unit (PICU) of Göztepe Prof. Dr. Süleyman Yalçın City Hospital. The translation and cultural adaptation will follow internationally accepted guidelines, including forward and backward translation, expert panel review, and pilot testing. Following pilot testing, psychometric evaluation will include assessments of internal consistency, test-retest reliability, and criterion validity by comparison with established clinical scores such as the Functional Status Scale (FSS), Glasgow Coma Scale (GCS), and Pediatric Logistic Organ Dysfunction (PELOD) score. Feasibility and safety will be analyzed based on completion rate, administration time, and occurrence of adverse events. The study population will include children aged 2-18 years who are admitted to the PICU and are clinically stable enough for bedside physical function assessment.

Conditions

Timeline

Start date
2025-09-01
Primary completion
2025-12-01
Completion
2025-12-10
First posted
2025-11-21
Last updated
2026-02-11

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07241455. Inclusion in this directory is not an endorsement.